Device success [ Time Frame: From start of index procedure to end of index procedure (Day 0) ] [ Designated as safety issue: No ]

Defined as, on a per device basis, as the achievement of successful delivery and deployment of the trial device at the intended target lesion and successful withdrawal of the delivery catheter.

Technical success [ Time Frame: From start of index procedure to end of index procedure (Day 0) ] [ Designated as safety issue: No ]

Defined on a per lesion basis as the attainment of a final residual stenosis of < 30% by core laboratory assessment at the intended target lesion(s).

Clinical Success [ Time Frame: Within 2 days after the index procedure or at hospital discharge, whichever is sooner ] [ Designated as safety issue: Yes ]

Clinical success, defined on a per subject basis, as the attainment of a final residual stenosis of < 30% by core laboratory assessment using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications.

Device success [ Time Frame: From start of index procedure to end of index procedure (Day 0) ] [ Designated as safety issue: No ]

Defined as, on a per device basis, the achievement of successful delivery and deployment of the trial device at the intended location and successful withdrawal of the delivery catheter.

Technical success [ Time Frame: From start of index procedure to end of index procedure (Day 0) ] [ Designated as safety issue: No ]

Defined, on a per lesion basis, as attainment of a final residual stenosis of < 30% by quantitative arteriography (QA) or as reported by the investigator

Procedure success [ Time Frame: Within 2 days after the index procedure or at hospital discharge, whichever is sooner ] [ Designated as safety issue: Yes ]

Defined, on a per subject basis, as technical success (attainment of a final residual stenosis of < 30% by QA or as reported by the investigator) without the occurrence of one or more of the following complications: bleeding requiring transfusion, emergent surgical bypass of the target lesion, or abrupt total occlusion of the stent requiring intervention.

To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or the native proximal popliteal artery (PPA).

have had a negative pregnancy test (serum HCG) within 14 days before treatment;

not be nursing at the time of treatment; and

agree at time of consent to use birth control during participation in this trial.

Subject has life expectancy > 12 months.

Angiographic Inclusion Criteria:

A single de novo or restenotic [not previously treated with stent, brachytherapy, laser, surgical bypass, or endarterectomy] native disease segment of the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) located within the following parameters: ≥1 cm below the femoral bifurcation in the SFA. ≥3 cm above the proximal margin of the intercondylar fossa.

Disease segment length visually estimated to be ≤ 14 cm (140 mm) and can be treated with one stent.

Disease segment visually estimated to be ≥ 50% stenosis or a total occlusion.

Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.

Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.

Subject has unstable angina defined as rest angina with ECG changes.

Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.

Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.

Subject is unable to take required antiplatelet therapy or requires any planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel, ticagrelor or ticlopidine within 30 days following the procedure.

Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 1 year.

Subject is currently participating in an investigational drug, biologic, or device study.

Subject is unable to understand or unwilling to cooperate with study procedures.

Subject is allergic to nickel, titanium, platinum, contrast media, or any study-required medication that is not amenable to pre-treatment.

Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hgb < 8.0) that cannot be corrected.

Subject requires general anesthesia for the procedure.

Subject has ischemic or neuropathic ulcers on either foot.

Subject has had any type of amputation to the ipsilateral extremity, or a contralateral extremity amputation other than of the toe or forefoot.

Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

Total occlusion of the ipsilateral iliac artery.

Target extremity has multilevel disease that requires other staged procedures within 30 days before or after the procedure.

Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.

Target vessel has an angiographically significant (> 50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure within 30 days before or after the procedure.

Target vessel has been previously treated at any location with a stent, or has been previously treated ≤ 5 cm from the proximal or distal margin of the target lesion with brachytherapy or laser.

Target lesion is within or adjacent to an aneurysm.

Target lesion or vessel has angiographic evidence of thrombus that is unresponsive to anti-thrombotic therapies.

Subject has a contralateral superficial femoral or proximal popliteal artery lesion that requires treatment within 30 days before or after the procedure.

Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3 cm.

Subject has evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion.

.Subject has any condition that precludes safe access to the target lesion or target vessel, e.g. severe calcification, excessive tortuosity.

Target lesion requires use of re-entry, ablative, cutting balloon, atherectomy, or similar devices to cross or treat the lesion.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects